The following data is part of a premarket notification filed by Escalon Medical Trek with the FDA for Single Dose Gas Injector.
| Device ID | K923397 |
| 510k Number | K923397 |
| Device Name: | SINGLE DOSE GAS INJECTOR |
| Classification | Calibrator, Pressure, Gas |
| Applicant | ESCALON MEDICAL TREK 820 SWAN DR. Mukwonago, WI 53149 |
| Contact | Ronald Hueneke |
| Correspondent | Ronald Hueneke ESCALON MEDICAL TREK 820 SWAN DR. Mukwonago, WI 53149 |
| Product Code | BXX |
| CFR Regulation Number | 868.2620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-09-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10853480006157 | K923397 | 000 |